Migration Testing for Food Contact Plastics: EU 10/2011 and FDA Requirements

Migration Testing for Food Contact Plastics: EU and FDA Requirements

Migration testing ensures that plastic packaging materials do not transfer harmful substances to food products. This article compares EU 10/2011 and FDA migration testing requirements.

EU 10/2011 Regulation Requirements

• Overall Migration Limit (OML): 10 mg/dm² or 60 mg/kg food
• Specific Migration Limits (SML): Substance-specific limits
• Test Conditions: Time/temperature based on intended use
• Food Simulants: Ethanol, acetic acid, olive oil, Tenax

FDA Migration Testing Protocol

• Extraction Solvents: n-Hexane, distilled water, 8% ethanol
• Extraction Conditions: 60°C for 2 hours (typical)
• Acceptance Criteria: ≤0.5 mg/in² surface area
• Heavy Metals: ≤1 ppm total

Test Methodology

EN 1186 series for overall migration:

• Part 2: Gravimetric method for simulants
• Part 5: Cell for liquid foods at elevated temperatures
• Part 11: Total immersion method

Specific Migration Analysis

GC-MS and HPLC analysis for:

• Antimony (catalyst residue): SML 0.04 mg/kg
• Acetaldehyde: ≤10 ppm for beverages
• Phthalates: SML 0.3-1.5 mg/kg depending on type
• Primary aromatic amines: NDL (not detectable)

Declaration of Compliance (DoC)

✓ EU DoC per Article 16 of Regulation 10/2011
✓ FDA Letter of Guarantee
✓ Test reports from accredited laboratories (ISO 17025)

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